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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidedline study performed according to the principles of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Diglycerin
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, own breed
- Weight at study initiation: 2,6 - 2,9 kg
- Age at study initiation: 3-5 months
- Diet: Altromin 2123 Haltungsdiät Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,5 ml of pure substance was applied.
Duration of treatment / exposure:
4 hours
Observation period:
30-60 min post application
24 hours post application
48 hours post application
72 hours post application
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The substance was applied under the surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skinarea and then covered with a semiocclusive bandage.

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 h / 48 h / 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
During the whole time of treatment no signs of irritation have been observed.

Any other information on results incl. tables

Detailed results (irritation scores):

 Time post appl.

30 -60 min

24 h

48 h 72 h

Animal number 

 1  2  3    1  2  3      1  2  3        1  2  3

 Erythema score

0

0 0        0  0  0  0  0  0    0  0  0  

Oedema score 

 0  0  0        0  0  0      0  0  0    0  0  0  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
With reference the reported scores and the absence of any signs of irritation during the whole study period the test itemdoes not need to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by semi-occlusive application of 0.5 mL to the intact flank of each of three New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 -60 minutes, 24, 48 and 72 hours after removal of the patch.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00 and the mean oedema score was 0.00 for all animals.

The application of the test item to the skin resulted in no signs of irritation. The test item is considered to be “not irritating” to rabbit skin.

With reference the reported scores and the absence of any signs of irritation during the whole study period the test item does not need to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).